CAPS Recalls Trophamine IV Infusion Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling Trophamine IV infusion bags because they failed sterility tests for microbial contamination.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4, and the hazard involves microbial contamination in a sterile injectable drug, posing a critical risk of serious injury or death.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling six bags of Trophamine 5g, Dextrose 10% IV infusion bags. The product is a sterile injectable compounded drug packaged in a corrugated box with a polystyrene insert. The recall is due to out-of-specification results for the sterility test, indicating microbial contamination.
The affected lot number is 37-74520, with a manufacture date of December 15, 2014, and an expiration date of December 24, 2014. The distribution pattern is listed as nationwide. The specific facility associated with the product name is St Lukes East Lees Summit (MO).
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- St Lukes East Lees Summit (MO) Protein Bag,Trophamine 5g, Dextrose 10%, Additives: Calcium Gluconate 4.65mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS,
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — IV Infusion
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- lot number 37-74520
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74520-0-6-R
- Disp ID: 37-1124617
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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